Plain English Summary
Background and study aims
Diabetes is a lifelong condition where the amount of sugar in the blood is too high. The aim of this study is to test the performance of the masked FreeStyle Libre Flash Glucose Monitoring System with and without a potential In-Reader correction, a device designed for people with diabetes to monitor their blood sugar.
Who can participate?
Patients aged 18 and over with type 1 or 2 diabetes
What does the study involve?
Participants wear two masked (blinded) sensors for up to 14 days and take at least four fingerstick blood sugar readings per day whilst wearing the sensors. Participants attend up to six visits at the clinical study site, three of the visits consist of up to 8 hours blood sampling at regular intervals.
What are the possible benefits and risks of participating?
There may be no direct benefit to the participant. The only risks of participating in this study are associated with blood sample collection. These are small but could include pain, bruising, local infection and fainting.
Where is the study run from?
BioKinetic Europe (UK)
When is the study starting and how long is it expected to run for?
September 2017 to March 2018
Who is funding the study?
Abbott Diabetes Care Ltd (UK)
Who is the main contact?
Dr Pamela Reid
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
ADC-UK-PMS-17031
Study information
Scientific title
Effectiveness of a potential in-reader correction for FreeStyle Libre flash sensor glucose data
Acronym
Study hypothesis
Assess the accuracy of the FreeStyle Libre Flash Glucose Monitoring System measured using percentage of readings that are within ±20% of the YSI reference value for glucose levels ≥ 80 mg/dL (4.4 mmol/L) and within ±20 mg/dL (1.1 mmol/L) for YSI glucose levels <80 mg/dL(4.4 mmol/L), with and without a potential In-Reader correction.
Ethics approval
Health and Social Care Research Ethics Committee A (HSC REC A), 11/09/2017, REC ref: 17/NI/0156; IRAS Project ID: 230816
Study design
Prospective single-arm trial
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Other
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Diabetes mellitus
Intervention
Participants will wear two masked sensors for a period of up to 14 days. They will be requested to obtain at least four fingerstick readings per day whilst wearing the sensors (using the built-in test strip port in one of the study readers). Participants will have three in-clinic visits; each in-clinic visit will consist of eight hours of reference sampling at 15 minute intervals, from an IV port.
Intervention type
Device
Phase
Drug names
Primary outcome measure
The point accuracy of the FreeStyle Libre Flash Glucose Monitoring System, measured using percentage of readings that are within ±20% of the YSI reference value for glucose levels ≥ 80 mg/dL (4.4 mmol/L) and within ±20 mg/dL (1.1 mmol/L) for YSI glucose levels <80 mg/dL(4.4 mmol/L), with and without a potential In-Reader correction. Measured on days 1, 2, 5, 7, 11 and 14 of sensor wear.
Secondary outcome measures
No secondary outcome measures
Overall trial start date
15/09/2017
Overall trial end date
31/03/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 18 years or over
2. Type 1 or type 2 diabetes requiring insulin therapy for at least 6 months prior to enrolment
3. Participant reports self-testing their blood glucose levels at least twice per day
4. Suitable venous access for study participation
Participant type
Other
Age group
Adult
Gender
Both
Target number of participants
Approximately 27 participants will be recruited
Participant exclusion criteria
1. Have a known allergy to medical grade adhesive
2. Be pregnant or planning to become pregnant within the study duration
3. Have skin abnormality at the application sites
4. Have a pacemaker or any other neurostimulators
5. Have concomitant medical condition which in the investigator’s opinion could interfere with the study or present a risk to the safety or welfare of the participant or study staff
6. Have anaemia
7. Currently participating in another clinical study
8. Participant is unsuitable for participation due to any other cause as determined by the Investigator
Recruitment start date
18/09/2017
Recruitment end date
28/02/2018
Locations
Countries of recruitment
United Kingdom
Trial participating centre
BioKinetic Europe
BT2 7BA
Trial participating centre
MAC Research Ltd
Nelson Street
Manchester
M13 9NQ
Funders
Funder type
Industry
Funder name
Abbott Diabetes Care
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
For-profit companies (industry)
Location
United States of America
Results and Publications
Publication and dissemination plan
Planned publication in a peer reviewed journal or conference presentation. Publication date January 2019.
IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from ADC_Witney_ClinicalAffairs@abbott.com.
Intention to publish date
01/01/2019
Participant level data
Available on request
Basic results (scientific)
Publication list